Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 208569
Company: TEVA PHARMS USA

Products on ANDA 208569

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TERIPARATIDE	TERIPARATIDE	0.56MG/2.24ML (0.25MG/ML)	SOLUTION;SUBCUTANEOUS	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 208569

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/16/2023	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/208569Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/06/2024	SUPPL-6	Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Medication Guide		Label is not available on this site.

Therapeutic Equivalents for ANDA 208569

TERIPARATIDE

SOLUTION;SUBCUTANEOUS; 0.56MG/2.24ML (0.25MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FORTEO	TERIPARATIDE	0.56MG/2.24ML (0.25MG/ML)	SOLUTION;SUBCUTANEOUS	Prescription	Yes	AP	021318	LILLY
TERIPARATIDE	TERIPARATIDE	0.56MG/2.24ML (0.25MG/ML)	SOLUTION;SUBCUTANEOUS	Prescription	Yes	AP	218771	ALMAJECT
TERIPARATIDE	TERIPARATIDE	0.56MG/2.24ML (0.25MG/ML)	SOLUTION;SUBCUTANEOUS	Prescription	No	AP	211097	APOTEX
TERIPARATIDE	TERIPARATIDE	0.56MG/2.24ML (0.25MG/ML)	SOLUTION;SUBCUTANEOUS	Prescription	No	AP	208569	TEVA PHARMS USA